This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.

Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.

Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.

Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.

Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.

Eligibility

Ages Eligible for Study:

70 Years and older (Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Type 2 diabetes

Insulin naive

Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets

HbA1c between 8% - 10.5%

Exclusion Criteria:

Secondary diabetes, MODY (Maturity Onset Diabetes of the Young)

Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator)

Proliferative retinopathy, maculopathy requiring treatment,

Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia

History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol

Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE (Mini-Mental State Examination) in the last six months) and any conditions as judged by the investigator

Participation in another clinical trial less than one month before inclusion in this trial

Illness requiring repeated hospitalisation

Known or suspected allergy to the insulin or any compositional component

Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)

Any other condition that the Investigator feels would interfere with trial participation or evaluation of results

Terminal illness

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506662